Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

February 23, 2021 updated by: EMS

Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
  • Experiment duration: 04 days.
  • 03 visits (days 0, 2 and 4).
  • Efficacy will be evaluated for back pain relief based on visual analogic scale.
  • Adverse events evaluation.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consent of the patient or legal guardian.
  • Men or women aged between 18 and 65.
  • Diagnosis of acute low back pain with moderate to severe pain (Visual Analogic score greater than 4 cm)

Exclusion Criteria:

  • fracture confirmed by X-ray
  • Diagnosis of infection, fever,
  • Pregnancy, lactation;
  • Diagnosis of fibromyalgia;
  • Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Naproxen
2 tablets every 8 hours for 4 days.
Drug: Naproxen
2 tablets every 8 hours for 4 days
EXPERIMENTAL: Ketorolac Tromethamine
10 drops every 8 hours for 4 days
Drug: Ketorolac Tromethamine
10 drops each 8 hours for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).
Time Frame: 4 days

The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit.

The response rate is calculated using the following formula:

Response rate = (VASvi - VASvf) / VASvi

Considering:

  • VASvi: VAS in the first visit;
  • VASvf: VAS at the last visit;
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety will be evaluated by the adverse events occurrences
Time Frame: day 4
Adverse events will be collected and followed in order to evaluate safety and tolerability
day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Investigators

  • Principal Investigator: Pérola Plaper, MD, Instituto do Coracao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

April 30, 2014

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRGEMS0611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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